Evidence map›Paper›PMID 30876480›Full record

Trial reportClinical epigenetics2019

Early detection of colorectal cancer based on presence of methylated syndecan-2 (SDC2) in stool DNA.

Yoon Dae Han, Tae Jeong Oh, Tae-Ha Chung, Hui Won Jang, Youn Nam Kim, Sungwhan An, Nam Kyu Kim

4 registry-linked trialsOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in Clinical epigenetics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 90 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
90citing papers in PubMed, 4 pooled it
7.8field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03146520 completednot on this map

Clinical Study for the Validation of Real Time qPCR for SDC2 Methylation in Stool DNA for Early Detection of Colorectal Cancer

TypeobservationalSponsorGenomictree, Inc.Ran2016 to 2018Enrolled634ConditionsColorectal Cancer, Polyps, Other Cancers, HealthyArmsEarlyTect Colon Cancer
NCT04304131 nacompletednot on this mapstarted 2020, after this paper: background citation

Colorectal Cancer Screening Using Stool DNA-based SDC2 Methylation Test

TypeinterventionalSponsorKyung Hee University Hospital at GangdongRan2020 to 2022Enrolled1,210ConditionsColorectal Cancer, Colon Polyp, HealthyArmsEarlytect Colon Cancer
NCT04515082 unknown statusnot on this mapstarted 2020, after this paper: background citation

Colorectal Cancer and Advanced Precancerous Neoplasm Screening Using Stool DNA-based SDC2 and SFRP2 Methylation Test in China, a Multi-Center Study

TypeobservationalSponsorChanghai HospitalRan2020 to 2021Enrolled4,800ConditionsColorectal Neoplasm, Colorectal Cancer, Adenomatous Polyps, AdenomaArmsStool-based SDC2 and SFRP2 DNA methylation test, FIT
NCT05255588 completednot on this mapstarted 2022, after this paper: background citation

A Multicenter, Single-blind, Prospective Clinical Trial to Evaluate the Clinical Performance of EarlyTect® CRC Test for the Early Detection of Colorectal Cancer in the Stool DNA From High-risk Group

TypeobservationalSponsorGenomictree, Inc.Ran2022 to 2024Enrolled2,358ConditionsColorectal Cancer, Advanced Colorectal Neoplasm, Advanced Adenomas, Non-neoplastic PolypsArmsEarlyTect® CRC test
3 · Its place in the literature

Who cites it

90 citing papers in PubMed, 4 syntheses or guidelines pooled it, 150 citations in OpenAlex.

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30 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Yoon Dae HanDivision of Colorectal Surgery, Department of Surgery, Severance Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro Seodaemun-gu, Seoul, 03722, South Korea.
Tae Jeong OhGenomictree, Inc., 44-6 Techno 10-ro Yuseong-gu, Daejeon, 34027, South Korea.
Tae-Ha ChungDepartment of Health Promotion, Severance check up, Health Promotion Center, Severance Hospital, 10 Tongil-ro, Jung-gu, Seoul, 04527, South Korea.
Hui Won JangDepartment of Health Promotion, Severance check up, Health Promotion Center, Severance Hospital, 10 Tongil-ro, Jung-gu, Seoul, 04527, South Korea.
Youn Nam KimDivision of Clinical Data Management Research, Clinical Trials Center, Severance Hospital, Yonsei University Health System, 50-1 Yonsei-ro Seodaemun-gu, Seoul, 03722, South Korea.
Sungwhan AnGenomictree, Inc., 44-6 Techno 10-ro Yuseong-gu, Daejeon, 34027, South Korea.
Nam Kyu KimDivision of Colorectal Surgery, Department of Surgery, Severance Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro Seodaemun-gu, Seoul, 03722, South Korea. namkyuk@yuhs.ac.ORCID 0000-0003-0639-5632
Severance Hospital · KRYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundColorectal cancer (CRC) screening can effectively reduce disease-related mortality by detecting CRC at earlier stages. We have previously demonstrated that the presence of SDC2 methylation in stool DNA is significantly associated with the occurrence of CRC regardless of clinical stage. The aim of this study was to evaluate the clinical performance of stool DNA-based SDC2 methylation test for CRC.

methodsAberrant SDC2 methylation in stool-derived DNA was measured by linear target enrichment (LTE)-quantitative methylation-specific real-time PCR (qMSP). Duplicate reactions of meSDC2 LTE-qMSP test were performed for stool samples obtained from CRC patients representing all stages (0-IV) and asymptomatic individuals who were subsequently underwent colonoscopy examination. To determine the diagnostic value of test in CRC and control groups, sensitivity and specificity were evaluated by receiver operating characteristic curve analysis.

resultsOf 585 subjects who could be evaluated, 245 had CRC, 44 had various sizes of adenomatous polyps, and 245 had negative colonoscopy results. Stool DNA-based meSDC2 LTE-qMSP showed an overall sensitivity of 90.2% with AUC of 0.902 in detecting CRC (0-IV) not associated with tumor stage, location, sex, or age (P > 0.05), with a specificity of 90.2%. Sensitivity for detecting early stages (0-II) was 89.1% (114/128). This test also detected 66.7% (2/3) and 24.4% (10/41) of advanced and non-advanced adenomas, respectively.

conclusionsResults of this study validated the capability of stool DNA based-SDC2 methylation test by LTE-qMSP for early detection of CRC patient with high specificity.

trial registrationClinicalTrials.gov, NCT03146520 , Registered 10 May 2017, Retrospectively registered; however, control arm was prospectively registered.

Indexed as

DNA MethylationAdultAgedArea Under CurveBiomarkers, TumorColorectal NeoplasmsEarly Detection of CancerEpigenesis, GeneticFecesFemaleGene Expression Regulation, NeoplasticHumansMaleMiddle AgedNeoplasm StagingProspective StudiesBiomarkers, TumorSDC2 protein, humanSyndecan-2BiomarkerColorectal cancerDNA methylationEarly detectionSyndecan-2

Identifiers

PMID30876480
PMCPMC6419806
OpenAlexW2940062333

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.